On November 22, 2025, Swissmedic released a Direct Healthcare Professional Communication (DHPC) concerning DIBASE® 10’000 (cholecalciferolum).…
Category: Europe
europe updates on medical device regulation and quality.
Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges
Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5…
Feedback Requested: Consultation on SaMD ‘Predetermined Change Control Plans’ Closing December 2025
The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment…
Temporary Approval Issued for Selectol 200 mg Tablets in French Packaging
Swissmedic has issued a temporary authorization allowing the distribution of Selectol 200 mg film-coated tablets in…
Swissmedic Updates: New Measures to Address Suicide Risk with Finasteride and Dutasteride
On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated…
Swissmedic’s Multilingual Initiative: Vigilance-News Now Available in Four Languages
Swissmedic has announced an important update to its Vigilance-News publication, ensuring accessibility for a broader audience.…
Swissmedic Releases Haemovigilance Annual Report 2024 With Key Findings on Transfusion Safety
Swissmedic, the Swiss agency for therapeutic products, has published its Haemovigilance Annual Report for the year…
Swissmedic Issues Recall for GlucoSaline B. Braun Infusion Solution Batch
Swissmedic has announced a recall of batch number 242867651 for the product GlucoSaline B. Braun Infusion…
Swissmedic Updates: Safety Revisions to Product Information Starting November 2025
Swissmedic has announced a significant update regarding the publication of safety-related revisions to product information. Effective…
Swissmedic Announces Initial Authorisation of ZYNYZ® – Key Updates for Industry Professionals
Swissmedic has granted the first authorisation for ZYNYZ®, marking a significant regulatory milestone. This development signals…